a physical dependence study in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether or not people with schizophrenia who take ly2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the drug when they stop using it. this trial consists of two phases: an open-label phase consisting of up to 4 weeks and a double-blind phase consisting of up to 3 weeks.

this was a short-term, multicenter, placebo-controlled, randomized withdrawal study comparing ly2140023 with placebo in the treatment of outpatients with diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr \[apa 2000\]) schizophrenia. patients were male or female outpatients, 18 to 65 years of age (inclusive) at study entry, with a diagnosis of schizophrenia as defined in the dsm-iv-tr the primary objective of this study was to assess whether ly2140023, when administered in an acute-treatment trial with flexible doses (40 mg or 80 mg) bid, was associated with physical dependence, as measured by the occurrence of withdrawal symptoms during a randomized withdrawal phase in patients diagnosed with schizophrenia. assessment was to be based on a comparison of randomized ly2140023-treated patients with those on placebo, as measured by the maximum of the 3-day moving average of the patient's total score on the discontinuation symptom checklist-modified rickels (dscmr).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia * female participants of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control * participants must require a modification of antipsychotic medication or the initiation of antipsychotic medication, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients * participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required, and be willing to perform all study procedures * participants must be able to understand the nature of the study and have given their own informed consent exclusion criteria: * have a clinical global impression-severity scale (cgi-s) score \>4 at study entry * have any other psychiatric diagnoses in addition to schizophrenia * participants who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia * participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses \>200 mg daily within 12 months prior to study entry, or who have received any clozapine at all during the month before study entry * participants who are actively suicidal * female participants who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study * have known, uncorrected, narrow-angle glaucoma * participants who have had electroconvulsive therapy (ect) within 3 months of study entry or who will have ect at any time during the study * participants with known medical history of human immunodeficiency virus positive (hiv+) status * participants who test positive for hepatitis c virus antibody or hepatitis b surface antigen (hbsag) with or without positive hepatitis b core total antibody * participants with current or a history of seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses * participants with a corrected qt interval (bazett's; qtcb) \>450 milliseconds (msec) (male) or \>470 msec (female) at study entry (based on the central vendor's electrocardiogram \[ecg\] overread) * have previously completed or withdrawn from this study, or any other study investigating ly2140023 or any predecessor molecules with glutamatergic activity * are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product for unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Keywords: schizophrenia, ly2140023, pomaglumetad methionil